Methods and devices for cardiac surgery

ABSTRACT

Methods for performing minimally invasive heart surgery include accessing a heart of a patient through a first incision on the left thorax of the patient, contacting the heart through the incision with a heart stabilizing device and/or a heart positioning device, introducing at least one coupling device through a second incision on the patient located apart from the first incision, coupling the coupling device with the heart stabilizing device or the heart positioning device, and performing a surgical procedure on the heart. Systems may include a retractor device, a heart stabilizing device, and a coupling device, for enhancing cardiac surgery. Any suitable heart surgery may be performed using methods, devices or systems of the present invention. In one embodiment, a CABG procedure is performed.

CROSS-REFERENCE TO OTHER APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/325,236 entitled “METHODS AND DEVICES FOR CARDIAC SURGERY,” filedDec. 14, 2011, which is a continuation of U.S. patent application Ser.No. 12/579,607 entitled “METHODS AND DEVICES FOR CARDIAC SURGERY,” filedOct. 15, 2009, which is a continuation of U.S. patent application Ser.No. 10/731,683, entitled “METHODS AND DEVICES FOR CARDIAC SURGERY,”filed Dec. 8, 2003, which claims priority to U.S. ProvisionalApplication No. 60/431,628, filed Dec. 6, 2002. Each of the abovereferenced patent applications is hereby incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, systems andmethods. More specifically, the device relates to devices, systems andmethods for performing and/or enhancing heart surgery procedures.

BACKGROUND OF THE INVENTION

Heart disease continues to be the leading cause of death in the UnitedStates, with coronary artery disease (CAD) accounting for much of themortality rate. As such, many interventional techniques have beendeveloped to treat CAD, and surgeries to treat the disease are common.One commonly performed surgery, for example, is coronary artery bypassgrafting (CABG), in which a graft, often from the internal mammaryartery, is used to bypass an occluded coronary artery to supply blood tothe heart.

Although CABG procedures are often quite successful, improvements insuch procedures are continually being sought, to reduce patientmorbidity and mortality and to improve outcomes. For example, atraditional technique for CABG surgery involves creating a largeincision through a patient's sternum, as well as stopping the heart andplacing the patient on a cardiopulmonary bypass machine. Many othertypes of heart surgery similarly require large incisions andcardiopulmonary bypass. Both of these components have significantpotential for patient morbidity and increase the overall risk of cardiacsurgical procedures. Thus, cardiac surgery techniques involving smallerincisions and/or techniques which can be performed on a beating hearthave been developed.

Generally, certain drawbacks typically occur when heart surgery isattempted through smaller incisions. It is often difficult for a surgeonto establish adequate visualization of a heart, to be able to manipulateand use surgical instruments on the heart, to stabilize the position ofthe heart, and/or to move the heart to a more advantageous positionthrough a relatively smaller incision. Basically, a smaller incisionwhich does not allow a surgeon to split the patient's sternum and widelyexpose the left thoracic cavity may not allow the surgeon to manipulatethe heart, perform the surgical procedure, and view the surgical fieldat the same time. If such inadequate access to the surgical site iscompounded with the difficulty of operating on a moving, beating heart,results of a CABG procedure or other heart surgery will often suffer.

Therefore, it would be advantageous to have devices, systems and methodsfor enhancing the performance of heart surgery. For example, it would beadvantageous to enable a surgeon to operate on a heart through a smallerincision than is conventionally used, while stabilizing and/orpositioning the heart with one or more devices inserted throughseparate, minimally invasive incisions. Such methods, devices andsystems would ideally be adaptable for either beating heart proceduresor procedures on a stopped heart using cardiopulmonary bypass. At leastsome of these objectives will be met by the present invention.

BRIEF SUMMARY OF THE INVENTION

Devices, systems and methods of the present invention provideenhancement of heart surgery procedures. Generally, the inventionprovides for accessing a patient's heart through an incision on the leftthorax, introducing a heart stabilizing device and/or a heartpositioning device through the incision, introducing one or morecoupling devices through separate incisions and coupling the couplingdevices with the heart stabilizing device and/or the heart positioningdevice to stabilize and/or position the heart. Introducing one or moreinstruments through incisions that are separate from the main incisionfor accessing the heart provides open area for a surgeon to visualizethe surgical field, insert additional instruments, manipulateinstruments, manipulate the heart and/or the like. Embodiments of theinvention may be used in either procedures involving a stopped heart andcardiopulmonary bypass or beating heart procedures.

In one aspect, a method of performing minimally invasive heart surgeryincludes: accessing a heart of a patient through a first incision on theleft thorax of the patient; contacting the heart, through the incision,with at least one of a heart stabilizing device and a heart positioningdevice; introducing at least one coupling device through a secondincision on the patient located apart from the first incision; couplingthe at least one coupling device with at least one of the heartstabilizing device and the heart positioning device; and performing asurgical procedure on the heart. In some embodiments, for example, thefirst incision is located between two ribs of the patient. Optionally,accessing the heart includes widening the first incision using at leastone retractor device.

In some embodiments, the contacting step comprises contacting the heartwith a heart stabilizing device and a heart positioning device.Optionally, such a method may further include using suction force toenhance contact of the heart stabilizing device and the heartpositioning device with the heart. In some embodiments, the introducingand coupling steps involve introducing a first elongate coupling devicethrough the second incision and coupling the first elongate couplingdevice with the heart stabilizing device. A method may further includeintroducing a second elongate coupling device through a third incisionon the patient at a location apart from the first and second incisionsand coupling the second elongate coupling device with the heartpositioning device. In one embodiment, the method also includes couplingeach of the first and second elongate coupling devices with at least onestabilizing apparatus for stabilizing the coupling devices. For example,coupling the coupling devices with the stabilizing apparatus maycomprise coupling the first coupling device with a first stabilizingarm, coupling the second coupling device with a second stabilizing arm,and coupling the first and second stabilizing arms with at least onestatic object. The static object, for example, may comprise at least aportion of an operating room table. In some embodiments, the method mayfurther include rigidifying the first and second stabilizing arms.

In some embodiments, the method may further comprise applying suctionforce with at least one of the heart stabilizing device and the heartpositioning device to enhance contact between the device(s) and theheart. The surgical procedure itself may be any suitable procedure. Forexample, performing the surgical procedure may comprise performing acoronary artery bypass graft procedure.

In another aspect, a system for enhancing minimally invasive heartsurgery comprises: at least one retractor device for enhancing access toa patient's heart through a first incision; a heart stabilizing devicehaving a tissue contacting surface and at least one suction apertureadjacent the surface; and a first coupling device for coupling with theheart stabilizing device through a second incision at a location on thepatient apart from the first incision. In some embodiments, the systemwill also comprise a heart positioning device having a tissue contactingsurface and at least one suction aperture and a second coupling devicefor coupling with the heart positioning device through a third incisionat a location on the patient apart from the first and second incisions.

The first and second coupling devices, in some embodiments, eachcomprise an elongate shaft having a proximal end, a distal end and meansfor coupling with the heart stabilizing device or the heart positioningdevice adjacent the distal end. The means for coupling, for example, maycomprise a collet or socket for coupling with a ball on the heartstabilizing device or the heart positioning device. In such embodiments,the first and second coupling devices may further include a tighteningdevice adjacent the proximal end of the shaft, for tightening the colletor socket around the ball. In other embodiments, the means for couplingcomprises a clamp for coupling with the heart stabilizing device or theheart positioning device. In some embodiments, the elongate shaftcomprises at least one flexible joint between the proximal end and thedistal end. The flexible joint, for example, may comprise at least onecollet or socket and ball joint.

Some embodiments of the system may suitably include a first flexible armfor coupling the first coupling device with at least one stable objectand a second flexible arm for coupling the second coupling device withthe stable object. In some embodiments, the first and second flexiblearms may be rigidified after coupling the first and second couplingdevices with the stable object. The stable object may include anysuitable object. In one embodiment, part of an operating room table isused. In some embodiments, each of the first and second flexible armscomprises: an elongate arm having a proximal end, a distal end and atleast one joint disposed between the proximal end and the distal end;means near the distal end for coupling the arm with a coupling device;means near the proximal end for coupling the arm with the stable object;and means for rigidifying the at least one joint of the arm. In someembodiments, the means near the distal end and the means near theproximal end each comprises a clamp.

In yet another embodiment, a device for enhancing minimally invasiveheart surgery comprises a heart stabilizing member and an elongatecoupling member having a proximal end, a distal end and means near thedistal end for coupling with the heart stabilizing member. The heartstabilizing member, for example, may comprise at least one tissuecontacting surface, at least one suction aperture for applying suctionforce to enhance contact between the tissue contacting surface and hearttissue, and at least one suction port for connecting with a source ofsuction. For example, the means for coupling with the heart stabilizingmember may comprise a collet or socket for coupling with a ball on theheart stabilizing member. In another embodiment, the means for couplingwith the heart stabilizing member comprises a clamp. The elongatecoupling member optionally further includes at least one flexible jointbetween the proximal end and the distal end. The joint, for example, maycomprise a collet or socket and ball joint. In other embodiments, thejoint comprises multiple flexible beads.

In still another embodiment, a device for enhancing minimally invasiveheart surgery comprises a heart positioning member and an elongatecoupling member having a proximal end, a distal end and means near thedistal end for coupling with the heart stabilizing member. The heartpositioning member may comprise at least one tissue contacting surface,at least one suction aperture for applying suction force to enhancecontact between the tissue contacting surface and heart tissue, and atleast one suction port for connecting with a source of suction. Again,the means for coupling with the heart positioning member may comprise acollet or socket for coupling with a ball on the heart positioningmember. Alternatively, the means for coupling may comprise threads forcoupling with complementary threads on a device, a slot for couplingwith a surface feature on the device, a clamp, or any other suitablemeans. As above, the elongate member may include one or more flexiblejoints.

In another aspect, a device for enhancing cardiac surgery comprises atleast one inflatable tissue contacting surface, at least one portcoupled with the tissue contacting surface for allowing inflation of thesurface, and an elongate shaft defining a proximal end and a distal end,the shaft being removably couplable with the inflatable tissuecontacting surface at or near the distal end. These and otherembodiments are described in further detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a patient with a system for performing aheart surgery in position on the patient, according to one embodiment ofthe present invention.

FIG. 2 is a perspective view of a device for enhancing heart surgery,according to one embodiment of the present invention.

FIG. 2A is a perspective view of a distal end of a coupling device and asurgical instrument, according to one embodiment of the presentinvention.

FIG. 2B is a perspective view of a distal end of a coupling device and asurgical instrument, according to another embodiment of the presentinvention.

FIG. 3 is a perspective view of a device for enhancing heart surgery,according to another embodiment of the present invention.

FIG. 4A is a top perspective view of a retractor positioned to retractan incision, according to one embodiment of the present invention.

FIG. 4B is a side view of an improved retractor blade, according to oneembodiment of the present invention.

FIG. 5 is a perspective view of an inflatable heart positioning device,according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Devices, systems and methods of the present invention provide forenhancement of heart surgery procedures. Generally, the inventionprovides for accessing a patient's heart through an incision on the leftthorax, introducing a heart stabilizing device and/or a heartpositioning device through the incision, introducing one or morecoupling devices through one or more separate incisions and coupling thecoupling device(s) with the heart stabilizing device and/or the heartpositioning device to stabilize and/or position the heart. Introducingone or more instruments through incisions that are separate from themain incision for accessing the heart provides a less cluttered surgicalfield, to provide the surgeon with enhanced visualization and room toinsert additional instruments, manipulate instruments, manipulate theheart, operate on the heart, perform an anastamosis and the like.Various embodiments of the invention may be used in procedures involvinga stopped heart and cardiopulmonary bypass, partial bypass, or inbeating heart procedures.

Generally, any suitable devices or combinations of devices may be usedwith methods of the present invention. One embodiment, for example, mayemploy one or more retractors as described in U.S. Pat. No. 6,309,349,entitled “Surgical Retractor and Stabilizing Device and Method for Use,”the entire disclosure of which is hereby incorporated by reference. Someembodiments may include one or more of the following: heart stabilizingdevices, such as those described in U.S. utility application Ser. No.10/297,791, a National Stage Application of PCT/US01/04263; heartpositioning devices, such as those described in U.S. Provisional PatentApplications 60/491,323, filed Jul. 29, 2003 and 60/519,837, filed Nov.11, 2003; heart ablation devices, such as those described in U.S.Provisional Patent Application 60/519,726, filed Nov. 12, 2003;instrument stabilizing platforms, such as those described in U.S.Provisional Patent Application No. 60/519,221, filed Nov. 11, 2003;and/or the like. The entire disclosures of these applications are herebyincorporated by reference.

Referring now to FIG. 1, a schematic diagram of a patient 10 is shownadjacent a rail 20 of an operating room table, with a surgical system inposition for enabling a heart surgery procedure. A surgical system mayinclude, in one embodiment, a retractor device 14 for retracting skinand other tissues surrounding a thoracic incision 12 on patient 10. Thesystem may also include a heart stabilizing device 18 and/or a heartpositioning device 16, each of which may be coupled with a couplingdevice 22, 24. Each coupling device 22, 24 may, in turn, be coupled witha flexible arm 30, 32, and each arm may be coupled with a stable object,such as rail 20. The combination shown in FIG. 1 and described herein isonly one embodiment of such a system, however, and should not beinterpreted as limiting the scope of the invention. In variousembodiments, many different combinations of surgical instruments,stabilizing devices, coupling devices, retractor devices and the likemay be used, without departing from the scope of the invention.Generally, therefore, any system for performing heart surgery in which adevice or part of a first device is introduced through a first incisionand second device is introduced through a second, separate incision andcoupled with the first device is contemplated within the scope of theinvention.

Generally, any suitable thoracic incision 12 may be used in accordancewith the present invention. For example, incision 12 may be made betweenthe 4th and 5th ribs in one embodiment. Once incision 12 is formed,retractor device 14, or one or more alternative retractor devices, maybe used to gain access to the patient's heart (not shown). In otherembodiments, other access means may be used, such as any suitableincision(s), port(s), puncture site(s) or the like. Once the hearttissue is accessible, heart stabilizing device 18 and/or heartpositioning device 16 are introduced through incision 12 and placed onthe surface of the heart. The surgeon may then position the device(s)16, 18 on the heart at or near a desired location, or may wait until alater time to position the device(s) 16, 18. Next, one or more small,secondary incisions 26, 28 are made at locations apart from thoracicincision 12, typically at nearby locations on the patient's thorax, butsuitably in other locations as well. The incisions may be small,stab-wound incisions of less than one inch in length, in someembodiments. In some embodiments, as in FIG. 1, two small incisions 26,28 are formed, to allow passage of two coupling devices 22, 24.Generally, any suitable incisions, ports, puncture sites, intravascularaccess sites, other access means or any combination thereof may be used.

A coupling device 22, 24, as described in further detail below,typically comprises an elongate shaft with means for coupling withstabilizing device 18 and/or positioning device 16 near the distal endof the shaft. Coupling device 22, 24, is introduced through a smallerincision 26, 28 and advanced through the patient, under the skin, toposition the distal end of the shaft at or near the surgical site,adjacent the heart. The coupling means are then used to attach couplingdevice 22, 24 to stabilizing device 18 or positioning device 16. Invarious embodiments, multiple coupling devices 22, 24 may be introducedthrough one incision, heart stabilizing device 18 and heart positioningdevice 16 may be coupled with the same coupling device 22, 24, and/oradditional heart contacting devices or coupling devices may be usedwithout departing from the scope of the present invention. Any suitablecombination of heart contacting devices and coupling devices iscontemplated within the scope of the invention.

Once coupling devices 22, 24 are coupled with stabilizing device 18 andpositioning device 16, coupling devices 22, 24 may be used to positionstabilizing and positioning devices 18, 16 on the heart. Once inposition, suction and/or other forces such as adhesives may be used toenhance contact between stabilizing and positioning devices 18, 16 andthe heart. In embodiments using suction, a source of suction, such as acannula, may be introduced through one of the smaller incisions 26, 28or through the larger, thoracic incision 12, depending on convenienceand preference of the surgeon. In either case, a suction cannula istypically connected with heart stabilizing device 18 or heartpositioning device 16 directly, rather than through coupling devices 22,24. In some embodiments, however, one or more suction cannulas may beattached to coupling device 22, 24, to facilitate introduction of thecannula to the surgical site, to reduce cluttering of the surgical site,or for any other suitable purpose.

When coupling devices 22, 24 have been coupled with heart stabilizingdevice 18 and heart positioning device 16 and the devices have beenpositioned on the heart and coupled with the heart via suction or otherforces, each coupling devices 22, 24 may then be coupled with one ormore stable objects via a flexible arm 32, 30. Flexible arms maycomprise any suitable devices for stabilizing coupling devices 22, 24.For example, arms 32, 30 may comprise elongate, flexible members havingdistal clamps 38, 40 at their distal ends and proximal clamps 34, 36 attheir proximal ends. Flexible arms 30, 32 may comprise metallic armshaving multiple joints, to allow flexibility while also being rigidenough to stabilize coupling members. In another embodiment, flexiblearms 30, 32 may be rigidifying, so that they may be manipulated into adesired position and then rigidified to hold their shape. In oneembodiment, for example, arms 30, 32 may be rigidified by applyingsuction. Flexible arms 30, 32 may be coupled at or near their proximalends, via proximal claims 34, 36 or other coupling components to anystable object or objects. In one embodiment, for example, the stableobject comprises a bed rail 20, but any other suitable object may beused.

Any of the steps described above, as well as additional steps, may beperformed in any suitable order, steps may be combined or eliminated, orthe like, without departing from the scope of the present invention. Forexample, in one embodiment, thoracic incision 12 may be formed, smallerincision(s) 26, 28 may be formed, coupling devices 22, 24 may beadvanced and then stabilizing device 18 and positioning device 16 may beplaced into the surgical site and coupled with coupling devices 22, 24.In another embodiment, flexible arms 30, 32 may be coupled with couplingdevices 22, 24 and with the stable object before being rigidified, whileother combinations are possible in other embodiments. Furthermore, asmentioned above, additional or other devices than those described abovemay be used, fewer devices may be used or the like, without departingfrom the scope of the invention.

With reference now to FIG. 2, a surgical apparatus 100 for enhancingheart surgery suitably includes a coupling device 101, coupled with aflexible arm 114 and a tissue stabilizing device 130 (or positioningdevice or other device). In one embodiment, coupling device 101 includesan elongate shaft 110 having proximal and distal ends (labeled arrows),which is coupled with a dial 112 or other actuation device at or nearits proximal end and heart stabilization device 130 at or near itsdistal end. Flexible arm 114 generally comprises an elongate, flexibledevice with a clamp 116 at or near its distal end for coupling withcoupling device 101. Clamp 116 may alternatively comprise any suitableconnective means.

Elongate shaft 110 of coupling device 101 is generally introduced into apatient through a minimally invasive incision 122 in the skin 120, andis then advanced distally until the distal end of coupling device 101 isvisible through a thoracic incision 126 over the heart 124. Elongateshaft 110 may have any suitable configuration. In some embodiments,shaft 110 includes one or more flexible, rigidifying sections. In someembodiments, such sections may rigidify by applying a vacuum to thatsection of shaft. Other embodiments may use different rigidifying means.Distal coupling means 118 at or near the distal end of coupling device101 may then be coupled with heart stabilizing device 130 viacomplementary coupling means 132 on device 130. In one embodiment,distal coupling means 118 comprises a socket or collet and complementarycoupling means 132 comprises a ball, or a ball on a post, which fitswithin distal coupling means 118. In another embodiment, distal couplingmeans 118 comprises a clamp and complementary coupling means 132comprises a rail or other feature onto which the clamp make take hold.Any suitable combination allowing coupling device 101 to attach to heartstabilization device 130 is contemplated. Various embodiments mayinclude, for example, a male and female screw connection, a magneticconnection, an adhesive connection, a snap-fit connection, apressure-fit connection or the like. At or near the proximal end ofcoupling device 101, dial 112 may in fact comprise any actuation device,such as but not limited to a knob, trigger, slide or the like.Similarly, dial 112 may be used to perform any function or combinationof functions with coupling device 101. For example, in one embodimentdial 112 is used to tighten and loosen distal coupling means 118 toallow coupling device 101 to be coupled with, tighten around and releaseheart stabilizing device 132. In other embodiments, dial 112 may controlone or more alternative or additional functions. Once coupling device101 is coupled with heart stabilizing device 130, it may be used toposition stabilizing device on the heart in a desired location andorientation.

With reference now to FIG. 2A, a coupling device distal end 140 is shownas an example of one embodiment of coupling means for coupling distalend 140 with a stabilizing device 149 or other suitable device. Aspreviously mentioned, any suitable coupling means for connectingcoupling device with a stabilization or other device is contemplatedwithin the scope of the invention. Thus, a ball and socket joint, a balland collet joint, any other suitable joint, an adhesive coupling means,a snap-fit or pressure fit coupling, or any other means may be used. Forexample, in yet another embodiment, as shown in FIG. 2A, distal end 140includes a curved slot 142 and stabilizing device 149 includes a knob148 which fits within slot 142 to provide coupling. In some embodiments,distal end 140 may also include a hollow lumen 146, such as a lumen foruse in applying a vacuum force, and a gasket 144. In some embodiments,stabilizing device 149 also includes a hollow lumen 150 such that whenstabilizing device 149 and distal end 140 are coupled together, the twolumens 146, 150 are in fluid communication. This may allow vacuum, air,fluid and/or the like to be transmitted from the coupling device to thestabilizing device 149. Such vacuum, for example, may be used to adherea supporting foot 152 of device 149 to a surface of the heart.

In another embodiment, as shown in FIG. 2B, a distal end 160 of acoupling device may include female threads 162 which are complementaryto male threads 166 on a stabilizing device 169 or other device. Again,distal end 160 may include a hollow lumen 164 and stabilizing device 169may also include such a lumen 168 such that when they are coupled, thetwo lumens communicate. Again, one possible use of such communicatinglumens 164, 168 might be to provide vacuum or suction force at a foot170 of stabilizing device 169. Any other suitable configuration ofdistal ends, stabilizing devices (or other devices) and coupling meansis contemplated within the scope of the invention. These examples areprovided for descriptive purposes only and are not intended to limit thescope of the invention in any way.

Referring now to FIG. 3, a similar apparatus 100 to that described inFIG. 2 is shown. In this embodiment, however, elongate shaft 110 ofcoupling device 101 includes multiple, flexible joints 210. Flexiblejoints 210 may comprise ball and socket or ball and collet joints or maysuitably include any other joint configuration. Joints 210 may providecoupling device 101 with enhanced flexibility and maneuverability withina patient to position the distal end of coupling device 101 in a desiredlocation. Any number of joints 210 may be used and any position orcombination of positions for joints 210 is contemplated. In someembodiments, dial 112 or one or more other actuators may be used tomanipulate joints 210. For example, joints 210 in some embodiments maybe moved via an actuator and/or may be tightened, to reduce flexibilityonce coupling device 101 is in a desired position. To further enhanceflexibility of apparatus 100, a series of beads 212 or bearings may beincorporated into the distal end of coupling device 101, into heartstabilizing device 130 or both. Any such flexible components may beused.

With reference now to FIG. 4A, a retractor device 400 for use in systemsand methods of the present invention suitably includes a frame 410, twoor more retractor blades 412 coupled with frame 410, and a crank 408 orother actuator coupled with frame 410. Frame 410 may include twovertical rods and two horizontal rods that are slidably coupled with thevertical rods. Crank 408 may be used to move the horizontal rodsrelative to the vertical rods, to thus increase the distance by whichblades 412 are separated and expand the width of an incision 414. Blades412 may comprise any suitable retractor blades and any number and sizeof blades 412 may be used. In some embodiments, retractor device 400will be configured to assist in separating ribs 416 as well as incision414. Again, any number, configuration, size and the like of blades 412may be used, and frame 412 may have any suitable shape, size andconfiguration. In some embodiments, only two or more blades may be used,without frame 410.

Turning now to FIG. 4B, a side view of a portion of retractor device 400is shown. In one embodiment, blade 412 includes a nerve protector 420 ordetent. Nerve protector 420 is generally configured to apply pressureagainst rib 416, without damaging an intercostal nerve 422 associatedwith rib 416. As such, nerve protector 420 may have any suitableconfiguration and, in some embodiments, may include a soft or paddedmaterial, to allow blade 412 to adequately retract tissue and applypressure against rib 416 without harming or damaging nerve 422.

More generally, any retraction device or combination of retractiondevices may be included as part of a system or method according to thepresent invention. In one embodiment, for example, an inflatableretractor may be used. For example, two blades of a retractor may becoupled to one another at opposite ends and may be inflated to allow aportion of each blade to expand, pushing the blades apart between theirconnected ends. In other embodiments, any combination of conventionalretractors or retractors not yet conceived may be used.

Similarly, any heart stabilizing device, heart positioning device and/orany other device may be used as part of a system or method of theinvention. As mentioned above, one heart stabilizing device may comprisethe OPVAC® heart stabilizer (available from Estech, Inc.,www.estechlics.com, the entire contents of said web site being herebyincorporated by reference). The heart positioning device may comprisethe Pyramid Positioner™ device (also available from Estech, Inc.).Alternatively, any other suitable devices may be used. Thus, the presentinvention is not limited to heart stabilizing devices and/or heartpositioning devices.

In one embodiment, an with reference now to FIG. 5, a stabilizing and/orpositioning device comprises an inflatable heart retractor 520 or“pillow retractor.” Inflatable retractor 520 comprises an inflatableretractor surface 522, coupled with an elongate shaft 528 via a flexibleconnector 526. Again, shaft 528 is coupled with a rapid disconnect 530,which may or may not include a flexible segment 532. Inflatableretractor 520 also includes means for inflating the retractor surface522, which may comprise, for example, an inflation cannula 524 within oroutside of elongate shaft 528. Inflatable heart retractor 520 may beparticularly advantageous in positioning the heart by placing theinflatable surface 522 in contact with a posterior portion of the heartand inflating the surface 522 to move the heart in an anteriordirection—i.e., closer to the surgeon. Many alternate embodiments ofinflatable retractor 520 may be developed within the scope of thepresent invention. Creating a space behind the heart may be veryadvantageous in visualizing the back of the heart and/or in maneuveringone or more surgical devices to operate on the back of the heart. Othervariations of inflatable retractors may be found in U.S. ProvisionalApplication No. 60/519,512, filed Nov. 12, 2003, the entire disclosureof which is hereby incorporated by reference.

Although the invention has been fully described above, in relation tovarious exemplary embodiments, various additions or other changes may bemade to the described embodiments without departing from the scope ofthe present invention. Thus, the foregoing description has been providedfor exemplary purposes only and should not be interpreted to limit thescope of the invention as set forth in the following claims.

What is claimed is:
 1. A method for performing minimally invasive heartsurgery in a patient, the method comprising: introducing a heartstabilizing device through a first incision on the patient, the heartstabilizing device comprising a tissue contacting surface; introducing afirst coupling device through a second incision on the patient, thefirst coupling device comprising a flexible, rigidifying portion havinga plurality of pieces and a wire that when tightened locks the pieces ofthe rigidifying portion; coupling the first coupling device with theheart stabilizing device; introducing a heart positioning device throughthe first incision on the patient, the heart stabilizing devicecomprising a tissue contacting surface; introducing a second couplingdevice through a third incision on the patient; and coupling the secondcoupling device with the heart positioning device.
 2. The methodaccording to claim 1, further comprising coupling the first couplingdevice with a stable object.
 3. The method according to claim 2, whereinthe stable object comprises at least one part of an operating roomtable.
 4. The method according to claim 2, comprising rigidifying theflexible, rigidifying portion of the first coupling device aftercoupling the first coupling device with the stable object.
 5. The methodaccording to claim 1, wherein the heart stabilizing device comprises asuction aperture adjacent the tissue contacting surface, the methodfurther comprising providing a vacuum at the suction aperture of theheart stabilizing device.
 6. The method according to claim 1, whereinthe heart positioning device comprises a suction aperture adjacent thetissue contacting surface, the method further comprising providing avacuum at the suction aperture of the heart positioning device.
 7. Themethod according to claim 1, further comprising contacting heart tissueof the patient with the tissue contacting surface of the heartstabilizing device.
 8. The method according to claim 1, furthercomprising contacting heart tissue of the patient with the tissuecontacting surface of the heart positioning device.
 9. The methodaccording to claim 1, wherein the second coupling device comprises aflexible, rigidifying portion having a plurality of pieces and a wirethat when tightened locks the pieces of the rigidifying portion intoplace.
 10. The method according to claim 1, wherein the heartstabilizing device comprises a ball, wherein the first coupling devicecomprises a collet or socket, and wherein coupling the first couplingdevice with the heart stabilizing device comprises coupling the ballwith the collet or socket.
 11. The method according to claim 10,comprising tightening the collet or socket around the ball using atightening device.
 12. The method according to claim 1, wherein theheart positioning device comprises a ball, wherein the second couplingdevice comprises a collet or socket, and wherein coupling the secondcoupling device with the heart positioning device comprises coupling theball with the collet or socket.
 13. The method according to claim 12,comprising tightening the collet or socket around the ball using atightening device.
 14. The method according to claim 1, wherein theheart stabilizing device comprises a surface feature, wherein the firstcoupling device comprises a slot, and wherein coupling the firstcoupling device with the heart stabilizing device comprises coupling theslot with the surface feature.
 15. The method according to claim 1,wherein the heart positioning device comprises a surface feature,wherein the second coupling device comprises a slot, and whereincoupling the second coupling device with the heart positioning devicecomprises coupling the slot with the surface feature.
 16. The methodaccording to claim 1, wherein the first coupling device comprisesthreads, wherein the heart stabilizing device comprises complementarythreads, and wherein coupling the first coupling device with the heartstabilizing device comprises coupling the threads with the complementarythreads.
 17. The method according to claim 1, wherein the secondcoupling device comprises threads, wherein the heart positioning devicecomprises complementary threads, and wherein coupling the secondcoupling device with the heart positioning device comprises coupling thethreads with the complementary threads.
 18. The method according toclaim 1, wherein the first coupling device comprises a clamp, andwherein coupling the first coupling device with the heart stabilizingdevice comprises coupling the clamp with the heart stabilizing device.19. The method according to claim 1, wherein the second coupling devicecomprises a clamp, and wherein coupling the second coupling device withthe heart positioning device comprises coupling the clamp with the heartpositioning device.
 20. A method for performing minimally invasive heartsurgery in a patient, the method comprising: introducing a heartstabilizing device through a first incision on the patient, the heartstabilizing device comprising a tissue contacting surface; introducing afirst coupling device through a second incision on the patient, thefirst coupling device comprising a flexible, rigidifying portion havinga plurality of pieces and a wire that when tightened locks the pieces ofthe rigidifying portion; and coupling the first coupling device with theheart stabilizing device.
 21. The method according to claim 20, furthercomprising coupling the first coupling device with a stable object. 22.The method according to claim 21, wherein the stable object comprises atleast one part of an operating room table.
 23. The method according toclaim 21, comprising rigidifying the flexible, rigidifying portion ofthe first coupling device after coupling the first coupling device withthe stable object.
 24. The method according to claim 20, whereincoupling the first coupling device with the heart stabilizing devicecomprises coupling a first flexible arm with the first coupling deviceand with the heart stabilizing device.
 25. The method according to claim20, wherein the plurality of pieces comprises a plurality of beads. 26.A method for performing minimally invasive heart surgery in a patient,the method comprising: introducing a heart stabilizing device through afirst incision on the patient, the heart stabilizing device comprising atissue contacting surface; introducing a first coupling device through asecond incision on the patient, the first coupling device comprising aflexible, rigidifying portion having a plurality of pieces and a wirethat when tightened locks the pieces of the rigidifying portion; andcoupling the first coupling device with the heart stabilizing devicewith a distal coupling means.
 27. The method according to claim 26,comprising tightening or loosening the distal coupling means with anactuation device.